Human Mass Balance Study With Bilastine

Faes Farma

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: [14C]-bilastine

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00572611

BILA 459-13

CR Study Number: 186781

EudraCT Number: 2007-003373-12

Details and patient eligibility

About

The primary objective of the study is to define the absorption and excretion kinetics of bilastine in man following oral administration, and to investigate the nature of the metabolites present in plasma and excreta. The secondary objective of the study is to assess the safety and tolerability of bilastine

Full description

Primary Endpoints are: Whole blood and plasma concentrations of total radioactivity and parent drug. Urine and faecal recovery of total radioactivity. Characterisation and identification of metabolites in plasma, urine and faeces.

Enrollment

6 patients

Sex

Male

Ages

30 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

No clinically important abnormal physical findings.
No clinically significant abnormalities in the results of laboratory evaluation.
Normal ECG.
Normal supine blood pressure and heart rate.
Body weight between 50 and 100 kg and body mass index between 18 and 30 kg/m2.
Able to communicate well with the investigator and to comply with the requirements of the entire study.
Provision of written informed consent to participate.
Subjects must agree to use an adequate method of contraception during the study and for 12 weeks after dosing.
Subjects must have a negative urine screen for drugs of abuse.
Subjects must have a regular bowel habit.

Exclusion criteria

Administration of any IMP within 12 weeks before entry to the study.
Use of any prescribed medication or St John's Wort within 14 days or OTC medication within 5 days of dosing.
Existence of any surgical or medical condition which, in the judgement of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the IMP.
History of any drug or alcohol abuse in the past 2 years, or alcohol consumption greater than 21 units per week.
Presence or history of allergy requiring treatment.
Hayfever is allowed unless it is active or has required treatment within the previous 2 months.
Donation or loss of greater than 400 mL of blood within 12 weeks before entry to the study.
Serious adverse reaction or serious hypersensitivity to any drug.
Presence of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or HIV 1 or HIV 2 antibodies at screening.
Administration of radiolabelled substances or exposure to significant radiation (eg serial x-ray or CT scans, barium meal etc) within the past 12 months.
Any ECG abnormality at screening (including QTc intervals of >430 ms).
Past medical history of clinically significant ECG abnormalities, or a family history of a prolonged QT interval syndrome.
Abnormal diet or substantial changes in eating habits within 30 days prior to study initiation.
Treatment with any known enzyme altering agents (barbiturates, phenothiazines, cimetidine, etc.) within 2 months prior to or during the study.